FDA.reportPublic FDA data

SHOCKPULSE

Primary DI
00821925043800
Brand
SHOCKPULSE
Company
Gyrus ACMI, LLC
Model
SPL-PR340
Device description
LITHOTRIPSY PROBE, REUSABLE, ShockPulse-SE 10.2 Fr (3.40 mm) x 396 mm
Published
2024-07-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
FEOLithotriptor, Ultrasonic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FEOLithotriptor, UltrasonicGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K142428000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K142428000Shock Pulse-SE Lithotripsy System CYBERWAND IICybersonics, Inc.2014-11-13FEO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00821925043800PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00821925043800008219250438008219250438000821925043800

GMDN Terms#

Term, Definition table
TermDefinition
Ultrasonic lithotripsy system probe, reusableA slender, metal, tubular device that is coaxially attached to an ultrasonic lithotripsy system handpiece [a hand-held acoustic transducer that produces ultrasound (US) waves] and intended to transmit US waves to calculi (stones) in the urinary tract (i.e., kidneys, ureters, and bladder) for their fragmentation. Its distal end is brought into contact with calculi and transmits the energy, breaking down the calculi in the body for removal through its lumen. This device is introduced through the working channel of an appropriate endoscope (e.g., a percutaneous nephroscope for ureteral stones). This is a reusable device intended to be sterilized prior to use.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure172 KiloPascal230 KiloPascal
Handling Environment Temperature270 Degrees Fahrenheit279 Degrees Fahrenheit

Sterilization Methods#

Method table
Method
Ethylene Oxide

Regulatory Flags#

DUNS number
007198742
Device count
1
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00821925034013Expandacell708907302018-09-13
00821925034020Gyrus ACMI708909072018-09-13
00821925034037Gyrus ACMI708909082018-09-13
00821925034532Gyrus ACMI8909112018-09-13
00821925037069Rhino Rocket708907292018-09-13
00821925037076Rhino Rocket708907312018-09-13
00821925037090Gyrus ACMI708907332018-09-13
00821925037106SlimLine708907342018-09-13
00821925037113Gyrus ACMI708907352018-09-13
00821925037120Gyrus ACMI708907372018-09-13
00821925037137Gyrus ACMI708907382018-09-13
00821925037144Gyrus ACMI708907392018-09-13
00821925037151Gyrus ACMI708907402018-09-13
00821925037168Gyrus ACMI708907412018-09-13
00821925037175Gyrus ACMI708907422018-09-13
00821925037182Gyrus ACMI708907432018-09-13
00821925037199Gyrus ACMI708907502018-09-13
00821925037205Gyrus ACMI708907512018-09-13
00821925037212Gyrus ACMI708907522018-09-13
00821925037229Gyrus ACMI708907532018-09-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613353125929LITHOCLASTE.M.S. Electro Medical Systems S.A.FEO2024-09-03
00821925044180SHOCKPULSEGyrus ACMI, LLCFEO2024-07-24
00821925044210SHOCKPULSEGyrus ACMI, LLCFEO2024-07-24
00821925044227SHOCKPULSEGyrus ACMI, LLCFEO2024-07-24
00821925044234SHOCKPULSEGyrus ACMI, LLCFEO2024-07-24
00821925044241SHOCKPULSEGyrus ACMI, LLCFEO2024-07-24
00821925043787SHOCKPULSEGyrus ACMI, LLCFEO2024-07-24
00821925043794SHOCKPULSEGyrus ACMI, LLCFEO2024-07-24
00821925043824SHOCKPULSEGyrus ACMI, LLCFEO2024-07-24
00821925043725SHOCKPULSEGyrus Acmi, Inc.FEO2024-07-24
00821925043732SHOCKPULSEGyrus Acmi, Inc.FEO2024-07-24
00821925043749SHOCKPULSEGyrus Acmi, Inc.FEO2024-07-24
00821925043756SHOCKPULSEGyrus Acmi, Inc.FEO2024-07-24
00821925043763SHOCKPULSEGyrus Acmi, Inc.FEO2024-07-24
00821925043817OlympusGyrus ACMI, LLCFEO2024-07-23
04953170026782Probe uncologging rodOLYMPUS MEDICAL SYSTEMS CORP.FEO2021-12-18
04953170318818Probe for LUS-2 2.0mm O.D.OLYMPUS MEDICAL SYSTEMS CORP.FEO2021-12-17
04953170026799Probe uncologging rodOLYMPUS MEDICAL SYSTEMS CORP.FEO2021-12-16
00821925043671ShockPulseGyrus ACMI, LLCFEO2020-03-03
00821925043688ShockPulseGyrus ACMI, LLCFEO2020-03-03
00821925043695ShockPulseGyrus ACMI, LLCFEO2020-03-03
00821925043701ShockPulseGyrus ACMI, LLCFEO2020-03-03
00821925043718ShockPulseGyrus ACMI, LLCFEO2020-03-03
00821925044203ShockPulseGyrus ACMI, LLCFEO2020-03-03
00821925043831ShockPulseGyrus ACMI, LLCFEO2020-03-02
00821925044197ShockPulseGyrus ACMI, LLCFEO2020-03-02
07613353125912LITHOCLASTE.M.S. Electro Medical Systems S.A.FEO2019-11-15
00821925039445Gyrus ACMIGyrus ACMI, LLCFEO2018-09-14
07613353156114LITHOCLASTE.M.S. Electro Medical Systems S.A.FEO2018-09-03
07613353156121LITHOCLASTE.M.S. Electro Medical Systems S.A.FEO2018-09-03